Compounded topical composition and method

ABSTRACT

A compounded topical composition may include an antiviral component, a topical base component, and a local anesthetic component. The antiviral component may include fine powder obtained by grinding oral tablets of one or more antiviral actives. The topical component may include the local anesthetic component. The local anesthetic component may be present in an amount between about 2% and about 8% by weight of the compounded topical composition and the antiviral component may be present in an amount between 4% and 12% by weight of the compounded topical composition. The antiviral component may include acyclovir, valaciclovir, penciclovir, famciclovir, or combinations thereof, and the topical base component may be a lidocaine topical, a lidocaine and prilocaine topical, or both.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 15/467,386 (now U.S. Pat. No. 10,231,924), filed Mar. 23, 2017. U.S.patent application Ser. No. 15/467,386 claims benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 62/312,290, filed onMar. 23, 2016. U.S. patent application Ser. No. 15/467,386 and U.S.Provisional Patent Application No. 62/312,290 are hereby incorporated byreference into this specification.

TECHNICAL FIELD

The present application relates to compounded pharmacological therapies.In particular, the present application relates to compounded topicalcompositions for antiviral therapies.

BACKGROUND

Transdermal creams are employed to deliver medication to the skin of apatient. Conventional compositions intended for topical administrationinclude EMLA cream, a eutectic mixture of lidocaine and prilocaine in anemulsified topical cream, such as disclosed by U.S. Pat. Nos. 6,299,902and 4,562,060, which are incorporated herein by reference in theirentireties. However, conventional transdermal creams may include variousdrawbacks, such as addressing limited medical conditions, creatingadverse side effects, and/or having limited shelf lives. Additionally,conventional methods of manufacturing transdermal creams may beinefficient and/or lack precision with the amount of active ingredients,or have other drawbacks.

SUMMARY

A compounded topical composition may include one or more activecomponents. The compounded topical composition may also include atopical base component that includes one or more of the activecomponents. Other active components may be compounded with topical basecomponent to formulate the compounded topical composition.

In various embodiments, active components may include an antiviralcomponent and a local anesthetic component. The compounded topicalcomposition may also include additional active components such as ananti-inflammatory component, an anticonvulsant component, a nervedepressant component, a muscle relaxant component, a NMDA (N-Methyl-D-aspartate) receptor antagonist component, an opiate or opioidagonist component, an antidepressant component, or combinations thereof.The active components may include one or more active agents provided inpowder form and that are combined with the topical base component andmixed. In some embodiments, the topical base component may be acommercial cream including all or a portion of one or more activecomponents. For example, the compounded topical composition may includea local anesthetic component comprising local anesthetic active agentsselected from lidocaine and prilocaine, wherein all or a portion of thelidocaine, prilocaine, or both are provided in the topical base. Invarious embodiments, the antiviral component comprises one or moreantiviral active agents selected from acyclovir, an acyclovir pro-drugsuch as valaciclovir, penciclovir, a penciclovir pro-drug such asfamciclovir, or combinations thereof. One or more active components mayinclude one or more of the active agents in the form of ground oraltablets that are dissolved, suspended, or combination thereof within thecompounded topical composition. For example, all or a portion of theground tablets may be dissolved while all or a remaining portion of thetablets may be suspended within the compounded topical composition. Thedissolved or suspended ground oral tablets may also be dispersed withinthe compounded topical composition.

In some embodiments, the topical base component includes the localanesthetic component. For example, the topical base component mayinclude a commercial cream, such as component comprising a commercialcream, such as lidocaine 2.5% and prilocaine 2.5% cream or lidocaine 5%ointment to which the antiviral component and, in some embodiments, oneor more additional active components are compounded.

In various embodiments, active components may include one or more finepowders including the corresponding active agents. In one example,active agents may be provided in fine powder form generated by grindingup one or more oral tablets containing the active agent. Fine powder mayallow for precise amounts of the active agent to be added to the topicalbase component. In one embodiment, active agents may also be provided inbulk powders, solutions, suspensions, or other formats. The compoundedtopical composition including fine powder generated from oral tabletsmay exhibit excellent storage characteristics and avoid separationand/or degradation of the active agent from the base for substantiallengths of time. In some embodiments, one or more active agents may beadded to the topical base component in the form of a solution,suspension, emulsion, or bulk powder.

In one aspect, the compounded topical composition may include lidocainein an amount between about 1% and about 4% by weight of the compoundedtopical composition; prilocaine in an amount between about 1% and about4% by weight of the compounded topical composition; and an antiviralcomponent between about 6% and about 10% by weight of the compoundedtopical composition. In one embodiment, the topical composition maycomprise about 2.25% by weight of each of lidocaine and prilocaine andabout 8% by weight acyclovir.

In another aspect, a compounded topical composition may includelidocaine in an amount between about 3% and about 6% by weight of thecompounded topical composition and an antiviral component between about6% and about 10% by weight of the compounded topical composition. In oneembodiment, the topical composition may comprise about 4.5% by weightlidocaine and about 8% by weight acyclovir.

In another aspect, a method of compounding one or more medications witha topical base component for the topical administration of a compoundedtopical composition therapy is be provided. The method may includecombining an antiviral component with a topical base component. Theantiviral component may include one or more antiviral actives selectedfrom acyclovir, an acyclovir pro-drug such as valaciclovir, penciclovir,a penciclovir pro -drug such as famciclovir, or combinations thereof,wherein at least one of the antiviral actives comprises a fine powder ofan oral tablet including the antiviral active that is generated bygrinding one or more of such oral tablets. Additional antiviral actives,including additional of the antiviral active contained in the finepowder generated from the grinding of oral tablets, may be provided insolution, suspension, emulsion, or bulk powder. In one embodiment, themethod includes forming the fine powder of the one or more selectedantiviral actives by grinding one or more tablets including theantiviral active. The method may include combining the antiviralcomponent and the topical base component. The antiviral component may becombined with the topical base component in one or more portions. Forexample, combining may include combining the fine powder including oneor more first antiviral actives before or after combining a fine powderor other format include one or more second antiviral actives oradditional first antiviral actives with the topical base component.

In one embodiment, the method may include combining a local anestheticcomponent and the topical base component. The local anesthetic componentmay be in the form of a solution, suspension, emulsion, bulk powder, orground oral tablet containing on or more local anesthetic actives of thelocal anesthetic component. In a further example, the topical basecomponent includes the local anesthetic component or portion thereof. Inone formulation, the topical base component comprises a commercialtopical composition including at least a portion of the local anestheticcomponent, such as a lidocaine and prilocaine cream. The method may alsoinclude adding the antiviral component and any additional components tothe topical base component containing lidocaine or both lidocaine andprilocaine, such that the compounded topical composition includeslidocaine or both lidocaine and prilocaine in an amount of between about3% to about 6% by weight lidocaine or about 1% to about 4% of each oflidocaine and prilocaine by weight. In further embodiments, the methodincludes adding an additional component selected from an anti-inflammatory component, an anticonvulsant component, a nerve depressantcomponent, a muscle relaxant component, a NMDA (N-Methyl-D-aspartate)receptor antagonist component, an opiate or opioid agonist component, anantidepressant component, and combinations thereof. The method mayinclude adding ground fine powder of one or more active agents to thetopical base component in a sufficient amount such that the compoundedtopical composition includes the active in an amount of between about10% and about 25% by weight of the compounded topical composition.

In one aspect, a method of producing a compounded topical compositioncomprises preparing a fine powder of an antiviral component comprisinggrinding one or more oral tablets of one or more antiviral actives toobtain a fine powder of the antiviral active; and combining theantiviral component and a topical base component comprising a localanesthetic component and mixing the combined components. The antiviralcomponent may be combined with the topical base component comprising thelocal anesthetic component in an amount such that the local anestheticcomponent is present in an amount between about 2% and about 8% byweight of the compounded topical composition and the antiviral componentin an amount between 4% and 12% by weight of the compounded topicalcomposition. The antiviral component may comprise one or more antiviralactives selected from acyclovir, valaciclovir, penciclovir, famciclovir,or combinations thereof, and the topical base component may comprise acommercially manufactured/available lidocaine topical, a commerciallymanufactured/available lidocaine and prilocaine topical, or both. Insome embodiments, the antiviral component may be acyclovir, acyclovirand at least one of valaciclovir or famciclovir, valaciclovir, orfamciclovir, wherein the topical base component comprises lidocaine 5%ointment, lidocaine 2.5% and prilocaine 2.5% cream, or combinationthereof.

In one example, the antiviral component comprises acyclovir andcombining the antiviral component and the topical base componentcomprising the local anesthetic component comprises combining asufficient amount of fine powder of acyclovir prepared from the grindingof oral tablets of acyclovir to obtain between about 6% and about 9%acyclovir by weight of the compounded topical composition. The topicalbase component may comprise lidocaine 5% ointment, lidocaine 2.5% andprilocaine 2.5% cream, or combination thereof.

In another example, the antiviral component comprises acyclovir andcombining the antiviral component and the topical base componentcomprising the local anesthetic component comprises combining asufficient amount of fine powder of acyclovir prepared from the grindingof oral tablets of acyclovir to obtain about 8% acyclovir by weight ofthe compounded topical composition. The topical base component maycomprise lidocaine 5% ointment, lidocaine 2.5% and prilocaine 2.5%cream, or combination thereof.

In yet another example, the antiviral component comprises acyclovir andthe topical base component comprises lidocaine 5% ointment, whereincombining the antiviral component and the lidocaine 5% ointmentcomprises combining a sufficient amount of fine powder of acyclovirprepared from the grinding of oral tablets of acyclovir to obtainbetween about 6% and about 9% acyclovir and greater than about 4%lidocaine by weight of the compounded topical composition.

In still yet another example, the antiviral component comprisesacyclovir and the topical base component comprises lidocaine 5%ointment, wherein combining the antiviral component and the lidocaine 5%ointment comprises combining a sufficient amount of fine powder ofacyclovir prepared from the grinding of oral tablets of acyclovir toobtain about 8% acyclovir and about 4.5% lidocaine by weight of thecompounded topical composition.

In one example, the antiviral component comprises acyclovir and at leastone of valaciclovir or famciclovir and the topical base componentcomprises lidocaine 5% ointment, wherein combining the antiviralcomponent and the lidocaine 5% ointment comprises combining a sufficientamount of fine powder of acyclovir and at least one of valaciclovir orfamciclovir prepared from the grinding of oral tablets of the acyclovirand the at least one of valaciclovir or famciclovir to obtain betweenabout 6% and about 9% acyclovir and the at least one of valaciclovir orfamciclovir and greater than about 4% lidocaine by weight of thecompounded topical composition.

In another example, the antiviral component comprises acyclovir and atleast one of valaciclovir or famciclovir and the topical base componentcomprises lidocaine 5% ointment, wherein combining the antiviralcomponent and the lidocaine 5% ointment comprises combining a sufficientamount of fine powder of acyclovir and the at least one of valacicloviror famciclovir prepared from the grinding of oral tablets of acyclovirand the at least one of valaciclovir or famciclovir to obtain about 8%acyclovir and the at least one of valaciclovir or famciclovir and about4.5% lidocaine by weight of the compounded topical composition.

In yet another example, the antiviral component comprises at least oneof valaciclovir or famciclovir and the topical base component compriseslidocaine 5% ointment, wherein combining the antiviral component and thelidocaine 5% ointment comprises combining a sufficient amount of finepowder of the at least one of valaciclovir or famciclovir prepared fromthe grinding of oral tablets of the at least one of valaciclovir orfamciclovir to obtain between about 6% and about 9% of the valacicloviror famciclovir and greater than 4% lidocaine by weight of the compoundedtopical composition.

In still yet another example, the antiviral component comprises at leastone of valaciclovir or famciclovir and the topical base componentcomprises lidocaine 5% ointment, wherein combining the antiviralcomponent and the lidocaine 5% ointment comprises combining a sufficientamount of fine powder of the at least one of valaciclovir or famciclovirprepared from the grinding of oral tablets of the at least one ofvalaciclovir or famciclovir to obtain about 8% of the at least one ofvalaciclovir or famciclovir and about 4.5% lidocaine by weight of thecompounded topical composition.

In one example, the antiviral component comprises acyclovir and thetopical base component comprises lidocaine 2.5% and prilocaine 2.5%cream, wherein combining the antiviral component and the lidocaine 2.5%and prilocaine 2.5% cream comprises combining a sufficient amount offine powder of acyclovir prepared from the grinding of oral tablets ofacyclovir to obtain between about 6% and about 9% acyclovir and betweenabout 1.5% and about 2.25% of both lidocaine and prilocaine by weight ofthe compounded topical composition.

In another example, the antiviral component comprises acyclovir and thetopical base component comprises lidocaine 2.5% and prilocaine 2.5%cream, wherein combining the antiviral component and the lidocaine 2.5%and prilocaine 2.5% cream comprises combining a sufficient amount offine powder of acyclovir prepared from the grinding of oral tablets ofacyclovir to obtain about 8% acyclovir and about 2.25% of both lidocaineand prilocaine by weight of the compounded topical composition.

In yet another example, the antiviral component comprises acyclovir andat least one of valaciclovir or famciclovir and the topical basecomponent comprises lidocaine 2.5% and prilocaine 2.5% cream, whereincombining the antiviral component and the lidocaine 2.5% and prilocaine2.5% cream comprises combining a sufficient amount of fine powder ofacyclovir and the at least one of valaciclovir or famciclovir preparedfrom the grinding of oral tablets of acyclovir and the at least one ofvalaciclovir or famciclovir to obtain between about 6% and about 9%acyclovir and the at least one of valaciclovir or famciclovir andbetween about 1.5% and about 2.25% of both lidocaine and prilocaine byweight of the compounded topical composition.

In still yet another example, the antiviral component comprisesacyclovir and at least one of valaciclovir or famciclovir and thetopical base component comprises lidocaine 2.5% and prilocaine 2.5%cream, wherein combining the antiviral component and the lidocaine 2.5%and prilocaine 2.5% cream comprises combining a sufficient amount offine powder of acyclovir and the at least one of valaciclovir orfamciclovir prepared from the grinding of oral tablets of acyclovir andthe at least one of valaciclovir or famciclovir to obtain about 8%acyclovir and the at least one of valaciclovir or famciclovir and about2.25% of both lidocaine and prilocaine by weight of the compoundedtopical composition.

In one example, the antiviral component comprises at least one ofvalaciclovir or famciclovir and the topical base component compriseslidocaine 2.5% and prilocaine 2.5% cream, wherein combining theantiviral component and the lidocaine 2.5% and prilocaine 2.5% creamcomprises combining a sufficient amount of fine powder of the at leastone of valaciclovir or famciclovir prepared from the grinding of oraltablets of the at least one of valaciclovir or famciclovir to obtainbetween about 6% and about 9% of the at least one of valaciclovir orfamciclovir and between about 1.5% and about 2.25% of both lidocaine andprilocaine by weight of the compounded topical composition.

In another example, the antiviral component comprises at least one ofvalaciclovir or famciclovir and the topical base component compriseslidocaine 2.5% and prilocaine 2.5% cream, wherein combining theantiviral component and the lidocaine 2.5% and prilocaine 2.5% creamcomprises combining a sufficient amount of fine powder of the at leastone of valaciclovir or famciclovir prepared from the grinding of oraltablets of the at least one of valaciclovir or famciclovir to obtainabout 8% of the at least one of valaciclovir or famciclovir and about2.25% of both lidocaine and prilocaine by weight of the compoundedtopical composition.

The above-described and other features and advantages of the presentdisclosure will be appreciated and understood by those skilled in theart from the following detailed description and appended claims.

DETAILED DESCRIPTION

The present embodiments may relate to a topically deliverable compoundedtopical composition for treatment of one or more viral ailments relatedto herpes simplex and varicella zoster, including herpes simplex virustype I (HSV-1) and herpes simplex virus type II (HSV-2). Variousembodiments of the compounded topical composition may be formulated andused to prevent or reduce the risk acquisition, spread, orflare-ups/outbreaks of herpes simplex infections, including, but notlimited to, labialis, genital, and neonatal infections. The compoundedtopical composition may be further formulated and used to prevent orreduce the risk of acquisition, spread, or flare-ups/outbreaks ofvaricella zoster infections, such as chickenpox and shingles. In someembodiments, the topically deliverable compounded topical compositionmay be formulated and used for treatment of one or more viral ailmentsrelated to Epstein-Barr virus and cytomegalovirus.

I. Compounded Topical Compositions

The composition may include a compounded topical composition thatincludes a topical base component to which one or more active componentshave been added and mixed. The topical base component may also includeone or more active components. One or more active components may includeone or more of the active agents in the form of ground oral tablets thatdisperse within the gel, e.g., the ground oral tablets may be dissolved,suspend, or combination thereof within the compounded topicalcomposition and therein dispersed. Unless indicated otherwise, topicalmay include formulation for administration to a body surface, such asskin or mucus membrane, and may include local delivery of one or moreactives, systemic delivery of one or more actives, or both. Topical mayalso include formulations for transdermal or transmucosal delivery.

The active components of the compounded topical composition may includean antiviral component and a local anesthetic component. Each activecomponent of the compounded tropical cream includes one or more activeswherein the local anesthetic component comprises one or more localanesthetic actives selected from lidocaine or prilocaine and theantiviral component comprises one or more antiviral actives selectedfrom acyclovir, an acyclovir pro-drug such as valaciclovir, penciclovir,a penciclovir pro-drug such as famciclovir, and combinations thereof.

In one embodiment, a compounded topical composition comprises a topicalbase component, a local anesthetic component and an antiviral component.Formulating the compounded topical composition may comprise combiningthe antiviral component with the topical base component and mixing. Theantiviral component may comprise one or more antiviral actives selectedfrom acyclovir, an acyclovir pro-drug such as valaciclovir, penciclovir,a penciclovir pro-drug such as famciclovir, and combinations thereof.The local anesthetic component may comprise one or more local anestheticactives selected from lidocaine, prilocaine, or combination thereof. Inone embodiment, formulating the compounded topical composition comprisescombining the antiviral component and at least a portion of the localanesthetic component and the topical base component.

The topical base component may include a colloid, emulsion, foam, gel orjelly, cream, ointment, lotion, powder, solution, suspension, spray,aerosol, or other suitable topical base format to deliver the activecomponents. In some embodiments, the topical base component may includeall or a portion of one or more active components, such as the localanesthetic component, or one or more active agents thereof. For example,the topical base component may include a lidocaine cream, a lidocaineand prilocaine cream, or both. Such creams may be in the form of a gel,ointment, emulsion, cream, suspension, or other suitable topical format.In some embodiments, the topical base component includes a commercialtransdermal cream format that includes all or a portion of the localanesthetic component. As used herein commercial components includecommercially manufactured and commercially available products. Forexample, the topical base may include a lidocaine 2.5% and prilocaine2.5% cream, such as EMLA or a generic. The topical base may include alidocaine 5% ointment. In one example, a commercially produced lidocaineand prilocaine cream comprises lidocaine, prilocaine, polyoxyethylenefatty acid esters, sodium hydroxide, purified water, and at least one ofcarboxypolymethylene or carbomer 934. When the topical base componentcomprises a commercially available topical cream that includes a portionof an active component, such as local anesthetics in lidocaine 2.5% andprilocaine 2.5% cream or lidocaine 5% cream, the topical composition maybe supplemented with additional of such active component via addition ofbulk powder, ground oral tablets, solution, suspension, or other formatincluding the active component.

The antiviral component and the topical base component may be combinedin amounts such that the compounded topical composition comprises theantiviral component in an amount between about 4% and about 12% byweight of the compounded topical composition and the local anestheticcomponent in about equivalent amounts of each of lidocaine andprilocaine between about 1.5% and about 2.5% by weight of the compoundedtopical composition. In another embodiment, the antiviral component andthe topical base component may be combined in amounts such that thecompounded topical composition comprises the antiviral component in anamount between about 4% and about 12% by weight of the compoundedtopical composition and the local anesthetic component in an amount oflidocaine between about 2.5% and about 5% by weight of the compoundedtopical composition.

In one formulation, the topical base component comprises a commerciallidocaine 2.5% and prilocaine 2.5% cream, a commercial lidocaine 5%ointment, or a combination of both and the antiviral component comprisesa ground powder generated from grinding commercial oral tabletscomprising the antiviral. In on embodiment, additional or supplementallocal anesthetic actives may be added to the topical base componentbefore or after the antiviral component is combined with the topicalbase component. When lidocaine or lidocaine and prilocaine are added orsupplemented, the additional or supplemental lidocaine or prilocaine maybe in the form of a solution, suspension, emulsion, gel, cream,ointment, powder (which may be a bulk powder or fine ground powderobtained from ground oral tablets), for example. For example, prilocainemay also be added to a lidocaine topical base component, such aslidocaine gel, cream, ointment, or lotion.

In some embodiments, the compounded topical composition comprises one ormore additional active components selected from an anti-inflammatorycomponent, an anticonvulsant component, a nerve depressant component, amuscle relaxant component, a NMDA (N-Methyl-D-aspartate) receptorantagonist component, an opiate or opioid agonist component, anantidepressant component, and combinations thereof.

The anti-inflammatory component may include one or moreanti-inflammatory actives such as NSAIDS (non-steroidalanti-inflammatory drug) selected from (1) oxicams—meloxicam andpiroxicam; (2) salicylic acid derivatives—aspirin, diflunisal,salsalate, and trilisate; (3) propionic acids—flurbiprofen, ibuprofen,ketoprofen, naproxen, and oxaprozin; (4) acetic acids—diclofenac,etodolac, indomethacin, ketorolac, nabumetone, sulindac, and tolmetin;(5) fenamates—meclofenamate; and/or (6) COX-2 inhibitors—celecoxib,rofecoxib, and valdecoxib; and (6) combinations thereof. Theanticonvulsant or nerve depressant component may comprise one or morenerve depressants and/or anticonvulsants actives selected fromgabapentin, topiramate, lamotrigine. The muscle relaxant component mayinclude one or more muscle relaxant actives selected baclofen,carisoprodol, chlorzoxazone, cyclobenzaprine, dantrolene, diazepam,metaxalone, methocarbamol, orphenadrine, quinine sulfate, tizanidine,and/or other muscle relaxants. The NMDA receptor antagonist componentmay include one or more NMDA receptor antagonist actives such asketamine The opiate or opioid agonist component may comprise one or moreopiate or opioid agonist actives selected from tramadol; one or more C2opiate agonists selected from oxycodone, morphine, methadone,hydromorphone, and fentanyl; one or more C3 opiate agonists selectedfrom hydrocodone, codeine, propoxyphene, butalbital, and pentazocine; orany combination thereof.

In some embodiments, one or more active components or one or moreactives thereof may be combined with the topical base component in theform of a solution, suspension, emulsion, or bulk powder.

In various embodiments, one or more of the active components or one ormore actives thereof may be in the form of powders combined with thetopical base component. The fine powders may be combined with thetopical base component and mixed to form the compounded topicalcomposition. The fine powders may be generated form ground oral tabletsand combining the active components and the topical base component byaddition and mixing may result in the fine powders being dissolved,suspended or combination thereof within the compounded topicalcomposition and therein dispersed throughout the composition.

In one embodiment, the compounded topical composition includes lidocainein an amount between about 0.5% and about 4.0% by weight of thecompounded topical composition; prilocaine in an amount between about0.5% and about 4.0% by weight of the compounded topical composition; andan antiviral component between about 4.0% and about 15% by weight of thecompounded topical composition, wherein the antiviral component is orcomprises acyclovir or one or more actives selected from acyclovir,valaciclovir, penciclovir, famciclovir, and combinations thereof. Inanother embodiment, the compounded topical composition includeslidocaine in an amount between about 2% and about 6% by weight of thecompounded topical composition and an antiviral component between about4% and about 15% by weight of the compounded topical composition,wherein the antiviral component is or comprises acyclovir or one or moreactives selected from acyclovir, valaciclovir, penciclovir, famciclovir,and combinations thereof. In one such example, the compounded topicalcomposition does not include prilocaine.

In one embodiment, the compounded topical composition includes the localanesthetic component comprising lidocaine, prilocaine, or both in anamount between about 2% and about 8% by weight of the compounded topicalcomposition and the antiviral component comprising acyclovir or one ormore actives selected from acyclovir, valaciclovir, penciclovir,famciclovir, and combinations thereof in an amount between about 4% andabout 12% by weight of the compounded topical composition. In oneexample, the local anesthetic component includes lidocaine andprilocaine and the antiviral component comprises or is acyclovir or oneor more actives selected from acyclovir, valaciclovir, penciclovir,famciclovir, and combinations thereof. In one example of the embodiment,the local anesthetic component includes lidocaine and prilocaine, eachin an amount of at least about 1%, about 1.5%, about 2%, about 2.5%,about 3%, about 3.5%, or about 4% by weight of the compounded topicalcomposition and the antiviral component comprises or is acyclovir in anamount of about 4%, about 4.5%, about 5%, about 6%, about 6.5%, about7%, about 7.5%, about 8%, about 8.5%, about 9%, about 9.5%, about 10%,about 10.5%, about 11%, about 11.5%, or about 12% by weight of thecompounded topical composition. In another example, the antiviralcomponent is selected from one or more actives comprising valaciclovir,penciclovir, famciclovir, and combinations thereof, in an amount ofabout 4%, about 4.5%, about 5%, about 6%, about 6.5%, about 7%, about7.5%, about 8%, about 8.5%, about 9%, about 9.5%, about 10%, about10.5%, about 11%, about 11.5%, or about 12% by weight of the compoundedtopical composition. In another example, the antiviral componentincludes acyclovir in an amount about 4%, about 4.5%, about 5%, about6%, about 6.5%, about 7%, about 7.5%, or about 8% by weight of thecompounded topical composition and at least one additional activeselected from valaciclovir, penciclovir, famciclovir, and combinationsthereof, in an amount of about 1%, about 1.5%, about 2%, about 2.5%,about 3%, about 3.5%, or about 4% by weight of the compounded topicalcomposition. In yet another example, the antiviral component comprisesor is valaciclovir in an amount of about 4%, about 4.5%, about 5%, about6%, about 6.5%, about 7%, about 7.5%, about 8%, about 8.5%, about 9%,about 9.5%, about 10%, about 10.5%, about 11%, about 11.5%, or about 12%by weight of the compounded topical composition. In yet still anotherexample, the antiviral component comprises penciclovir, famciclovir, ora combination thereof, in an amount of about 4%, about 4.5%, about 5%,about 6%, about 6.5%, about 7%, about 7.5%, about 8%, about 8.5%, about9%, about 9.5%, about 10%, about 10.5%, about 11%, about 11.5%, or about12% by weight of the compounded topical composition. In another example,the local anesthetic component includes lidocaine and prilocaine, eachin an amount between about 1.5% and about 2.5%, about 2% and about 2.5%,or about 2.25% by weight of the compounded topical composition and theantiviral component comprises or is acyclovir in an amount between about5% and about 10%, about 6% and about 9%, about 7% and about 9%, or about8% by weight of the compounded topical composition. In one example, theantiviral component is selected from one or more actives comprisingvalaciclovir, penciclovir, famciclovir, and combinations thereof, in anamount between about 5% and about 10%, about 6% and about 9%, about 7%and about 9%, or about 8% by weight of the compounded topicalcomposition. In another example, the antiviral component includesacyclovir in an amount between about 2% and about 8%, about 2% and about6%, about 2% and about 4%, or about 6% by weight of the compoundedtopical composition and at least one additional active selected fromvalaciclovir, penciclovir, famciclovir, and combinations thereof, in anamount between about 1% and about 8%, about 2% and about 6%, about 3%and 5%, about 4% and about 6%, or about 3% by weight of the compoundedtopical composition. In yet another example, the antiviral componentcomprises or is valaciclovir in an amount between about 5% and about10%, about 6% and about 9%, about 7% and about 9%, or about 8% by weightof the compounded topical composition. In yet still another example, theantiviral component comprises penciclovir, famciclovir, or a combinationthereof, in an amount between about 5% and about 10%, about 6% and about9%, about 7% and about 9%, or about 8% by weight of the compoundedtopical composition.

In one embodiment, the compounded topical composition includes the localanesthetic component in an amount between about 2% and about 8% byweight of the compounded topical composition and the antiviral componentin an amount between about 4% and about 12% by weight of the compoundedtopical composition wherein the local anesthetic component compriseslidocaine and little or no prilocaine. In one example, the antiviralcomponent is acyclovir or one or more actives selected from acyclovir,valaciclovir, penciclovir, famciclovir, and combinations thereof. In afurther example, the anesthetic component is lidocaine and thecompounded topical composition does not include prilocaine. In oneexample of the embodiment, the local anesthetic component is or includeslidocaine and the antiviral component is or comprises acyclovir or oneor more actives selected from acyclovir, valaciclovir, penciclovir,famciclovir, and combinations thereof. In other such examples, the localanesthetic component comprises or is lidocaine and the antiviralcomponent comprises or is acyclovir or one or more actives selected fromacyclovir, valaciclovir, penciclovir, famciclovir, and combinationsthereof. In one example, the local anesthetic component comprises or islidocaine in an amount of at least about 1%, about 1.5%, about 2%, about2.5%, about 3%, about 3.5%, or about 4% by weight of the compoundedtopical composition and the antiviral component comprises or isacyclovir in an amount of about 4%, about 4.5%, about 5%, about 6%,about 6.5%, about 7%, about 7.5%, about 8%, about 8.5%, about 9%, about9.5%, about 10%, about 10.5%, about 11%, about 11.5%, or about 12% byweight of the compounded topical composition. In another example, theantiviral component is selected from one or more actives comprisingvalaciclovir, penciclovir, famciclovir, and combinations thereof, in anamount of about 4%, about 4.5%, about 5%, about 6%, about 6.5%, about7%, about 7.5%, about 8%, about 8.5%, about 9%, about 9.5%, about 10%,about 10.5%, about 11%, about 11.5%, or about 12% by weight of thecompounded topical composition. In another example, the antiviralcomponent comprises acyclovir in an amount about 4%, about 4.5%, about5%, about 6%, about 6.5%, about 7%, about 7.5%, or about 8% by weight ofthe compounded topical composition and at least one additional activeselected from valaciclovir, penciclovir, famciclovir, and combinationsthereof, in an amount of about 1%, about 1.5%, about 2%, about 2.5%,about 3%, about 3.5%, or about 4% by weight of the compounded topicalcomposition. In yet another example, the antiviral component comprisesor is valaciclovir in an amount of about 4%, about 4.5%, about 5%, about6%, about 6.5%, about 7%, about 7.5%, about 8%, about 8.5%, about 9%,about 9.5%, about 10%, about 10.5%, about 11%, about 11.5%, or about 12%by weight of the compounded topical composition. In yet still anotherexample, the antiviral component comprises penciclovir, famciclovir, ora combination thereof, in an amount of about 4%, about 4.5%, about 5%,about 6%, about 6.5%, about 7%, about 7.5%, about 8%, about 8.5%, about9%, about 9.5%, about 10%, about 10.5%, about 11%, about 11.5%, or about12% by weight of the compounded topical composition. In another example,the local anesthetic component is lidocaine in an amount between about2% and about 8%, about 3% and about 7%, about 4% and about 6%, about 4%and about 5%, or about 4.5% by weight of the compounded topicalcomposition and the antiviral component includes acyclovir in an amountbetween about 5% and about 10%, about 6% and about 9%, about 7% andabout 9%, or about 8% by weight of the compounded topical composition.In one example, the antiviral component is selected from one or moreactives comprising valaciclovir, penciclovir, famciclovir, andcombinations thereof, in an amount between about 5% and about 10%, about6% and about 9%, about 7% and about 9%, or about 8% by weight of thecompounded topical composition. In another example, the antiviralcomponent includes acyclovir in an amount between about 2% and about 8%,about 2% and about 6%, about 2% and about 4%, or about 6% by weight ofthe compounded topical composition and at least one additional activeselected from valaciclovir, penciclovir, famciclovir, and combinationsthereof, in an amount between about 1% and about 8%, about 2% and about6%, about 3% and 5%, about 4% and about 6%, or about 3% by weight of thecompounded topical composition. In yet another example, the antiviralcomponent comprises or is valaciclovir in an amount between about 5% andabout 10%, about 6% and about 9%, about 7% and about 9%, or about 8% byweight of the compounded topical composition. In yet still anotherexample, the antiviral component comprises penciclovir, famciclovir, ora combination thereof, in an amount between about 5% and about 10%,about 6% and about 9%, about 7% and about 9%, or about 8% by weight ofthe compounded topical composition.

In one embodiment, the topical composition comprises about 2.25% byweight lidocaine and prilocaine, respectively, and about 8% by weightacyclovir. In another embodiment, the topical composition comprisesabout 4.5% by weight lidocaine and about 8% by weight acyclovir. In onesuch embodiment, the compounded composition does not include prilocaine.

In any of the above embodiments, the compound topical composition mayinclude one or more additional active components. In one example, thecompounded topical composition includes an anti-inflammatory componentcomprising one or more actives, such as flurbiprofen or nabumetone, inan amount between about 5.0% and about 25.0% of the topical compositionby weight. In this or another example, the compounded topicalcomposition includes a nerve depressant component comprising one or moreactives, such as gabapentin, in an amount between about 5.0% and about15.0% of the compounded topical composition by weight. In either of theabove or another example, the compounded topical composition includes amuscle relaxant component comprising one or more actives, such ascyclobenzaprine, in an amount between about 0.5% and about 4.0% byweight of the compounded topical composition. In one embodiment, thecompounded topical composition may comprise about 2.0% lidocaine, about2.0% prilocaine, about 4.5% lidocaine, about 8% acyclovir and at leastone of about 4% to 6% gabapentin, about 0.5% to 1.0% cyclobenzaprine,and about 5% to about 10% flurbiprofen or about 10% to about 20%nabumetone. In one embodiment, acyclovir is present in the compoundedtopical composition in an amount about 1% to about 10%, about 4% toabout 9%, or about 5% to about 8% by weight and lidocaine or lidocaineand prilocaine are present in the compounded topical composition anamount about 4% to about 5% by weight. Additional active components mayalso be present such as about 1% to about 10% gabapentin, about 1% toabout 10%, about 2% to about 8%, about 3% to about 7%, or about 4% toabout 6% by weight diclofenac, about 0.5% to about 2%, about 0.5% toabout 1.5% by weight cyclobenzaprine.

II. Methods of Compounding

A method of compounding one or more medications with a topical basecomponent for the topical administration of a compounded topicalcomposition is provided.

The method may include combining one or more active components oractives thereof and the topical base component and mixing, which mayinclude milling in an ointment mill. One or more of the activecomponents or actives thereof may be added to the topical base componentas a solution, suspension, colloid, emulsion, bulk powder, or groundoral tablet. Thus, the method may include preparing the one or moreactive components or one or more actives thereof for addition to thetopical base component. In one example, preparing the one or more activecomponents or one or more actives thereof for addition to the topicalbase component includes grinding commercial oral tablets comprising theactives. In this or another example, preparing the one or more activecomponents or one or more actives thereof for addition to the topicalbase component comprises dissolving, solubilizing, wetting, orsuspending one or more actives in solution. The actives may be groundoral tablets or bulk powder. Dissolving, solubilizing, wetting, orsuspending may include combining the one or more actives with water forinjection or irrigation, DMSO, alcohol, or other suitable liquid.

In one embodiment, the method includes forming a fine powder of anantiviral component comprising grinding up one or more antiviral oraltablets and combining the antiviral component and the topical basecomponent. In this or another embodiment, the method may includecombining the local anesthetic component and the topical base component.The local anesthetic component may be in the form of a solution,suspension, emulsion, bulk powder, or find ground oral tablet containingon or more local anesthetics of the local anesthetic component. Thus,the method may include grinding oral tablets of one or more localanesthetic actives. In a further example, the topical base componentincludes the local anesthetic component or portion thereof. In oneformulation, for example, the topical base component comprises acommercial transdermal cream including the local anesthetic componentsuch as a lidocaine or lidocaine and prilocaine cream, which may includea gel, ointment, or emulsion. The fine powder of active agents may beadded to the topical base containing lidocaine or both lidocaine andprilocaine, such that the compounded topical composition includeslidocaine or both lidocaine and prilocaine in an amount by weight of thecompounded topical composition described above.

A method of compounding may include providing a topical base componenthaving one or more local anesthetics; and adding to the base a finepowder of medication comprising: one or more antiviral actives of theantiviral component. In a further example, the method may furtherinclude adding to the topical base component a fine powder of actives ofone or more additional components. The one or more additional componentsmay be selected from an anti-inflammatory component, an anticonvulsantcomponent, a nerve depressant component, a muscle relaxant component, aNMDA (N-Methyl-D-aspartate) receptor antagonist component, an opiate oropioid agonist component, an antidepressant component, and combinationsthereof. One, more, of all actives of the additional components may beadded to the topical base component in the form of a solution,suspension, emulsion, bulk powder, or ground commercial tablet. In onesuch embodiment, the method may include preparing a one or more of theactives of the additional components for addition to the topical basecomponent comprising grinding commercial tablets comprising the activesto form a fine powder.

As described above, the active agents in fine powder form may begenerated from grinding up oral tablets containing the active agent. Thecompounded topical composition may include the ground tablets dissolvedor suspended, including partially dissolved or suspend, within the bodyof the composition. The fine powder may allow for precise amounts of theactive agents to be added to the base. The ground tablets dissolved,suspended, or both may be dispersed throughout the compounded topicalcomposition. The compounded topical composition may exhibit excellentstorage characteristics, and avoid separation and/or degradation of theactive agents from the base for substantial lengths of time.

The method may comprise providing a topical base component comprisingone or more local anesthetic actives of the local anesthetic component.Primary examples of local anesthetics that the topical compositions andbase composition disclosed herein may employ include, but are notlimited to, lidocaine, prilocaine, benzocaine, and/or tetracaine. Insome embodiments, the topical base component includes a commercialtransdermal format that includes all or a portion of the localanesthetic component. For example, the topical base component mayinclude lidocaine and prilocaine cream (e.g., EMLA cream or generic),lidocaine cream, or other topical base comprising lidocaine, prilocaine,or both, formulated to topically deliver lidocaine, prilocaine, or bothat skin or mucous membrane. In one embodiment, the local anestheticcomponent may comprise between about 2% and about 6.0% by weight of thecompounded topical composition. Other amounts may be used, includingthose discussed elsewhere herein. The topical base component may includeadditional, fewer, or alternate ingredients. Preferably, the topicalbase component may include lidocaine and/or prilocaine. In oneembodiment, the topical base component may comprise an equal amount oflidocaine and prilocaine, such as between about 2.0% and about 3.0% byweight. Other amounts may be used, including those discussed elsewhereherein.

The method may comprise combining an additional active component and thetopical base component comprising an anti-inflammatory component. Theanti-inflammatory component may one or more NSAIDS. Theanti-inflammatory component may include one or more of the active agentsadded to the topical base component in the form of a solution,suspension, emulsion, or fine powder. In one example, the compoundedtopical composition includes between about 1% and about 5% by weightanti-inflammatory component wherein the anti-inflammatory componentcomprises at least one NSAID selected from meloxicam, piroxicam,flurbiprofen, ketoprofen, naproxen, oxaprozin, diclofenac, nabumetone.Other anti-inflammatory actives or amounts may be used, including thosediscussed elsewhere herein.

The method may comprise combining an additional active component and thetopical base component comprising an anticonvulsant component. Theanticonvulsant component may include one or more of the active agentsadded to the topical base component in the form of a solution,suspension, emulsion, or fine powder. In one example, the compoundedtopical composition includes between about 1% and about 5% by weightanticonvulsant component wherein the anticonvulsant component comprisesat least one of lamotrigine or topiramate. Other anticonvulsant activesand amounts may be used, including those discussed elsewhere herein.

The method may comprise combining an additional active component and thetopical base component comprising a nerve depressant component. Thenerve depressant component may include one or more of the active agentscombined with the topical base component in the form of a solution,suspension, emulsion, or fine powder. In one example, the compoundedtopical composition includes between about 1% and about 5% by weightnerve depressant component wherein the nerve depressant componentcomprises gabapentin. Other nerve depressant actives and amounts may beused, including those discussed elsewhere herein.

The method may comprise combining an additional active component and thetopical base component comprising a muscle relaxant component. Themuscle relaxant component may include one or more of the active agentsadded to the topical base component in the form of a solution,suspension, emulsion, or fine powder. In one example, the compoundedtopical composition includes between about 1% and about 5% by weightmuscle relaxant component wherein the muscle relaxant componentcomprises cyclobenzaprine. Other muscle relaxant actives and amounts maybe used, including those discussed elsewhere herein.

The method may comprise combining an additional active component and thetopical base component comprising a NMDA receptor antagonist component.The NMDA receptor antagonist component may include one or more of theactive agents added to the topical base component in the form of asolution, suspension, emulsion, or fine powder. In one example, thecompounded topical composition includes between about 1% and about 5% byNMDA receptor antagonist component wherein the NMDA receptor antagonistcomponent comprises ketamine Other NMDA receptor antagonist actives andamounts may be used, including those discussed elsewhere herein.

The method may comprise combining an additional active component and thetopical base component comprising an opiate or opioid agonist component.The opiate or opioid agonist component may include one or more of theactive agents added to the topical base component in the form of asolution, suspension, emulsion, or fine powder. In one example, thecompounded topical composition includes between about 1% and about 5% byweight opiate or opioid agonist component wherein the opiate or opioidagonist component comprises one or more of the C2 and C3 opiate agonistsnamed above, tramadol, or a combination thereof. Other opiate or opioidagonist actives and amounts may be used, including those discussedelsewhere herein.

In one embodiment, the method may include addition of excipients to thetopical base component. In another embodiment, the method does notinclude addition of excipients to the topical base component. Forexample, in one embodiment the topical base component includes acommercially manufactured composition containing all or a portion of thelocal anesthetic component, such as lidocaine and prilocaine cream, gel,ointment, lotion, etc. or lidocaine cream, gel, ointment, lotion, etc.,and the method does not include addition of excipients, e.g., additionalexcipients to the topical base component.

A method of compounding active components with a topical base componentusing a fine powder of one or more actives is disclosed herein. In thisembodiment, a topical base component, such as a commercial lidocaine orlidocaine and prilocaine cream, should be selected. The preparer, suchas a pharmacist, should calculate the weight of powders needed. Then,the preparer should grind the actives, such as oral tablets containingthe actives, into fine powder and weigh the powder. The preparer shouldbring to total weight with the lidocaine or lidocaine and prilocainecream and mix well. The mixture should be milled in an ointment mill asnecessary to acquire the desired smooth consistency. After which, thepreparer should mix thoroughly and package appropriately.

In a further embodiment, the method may include selecting a topical basecomponent for a transdermal cream or gel. The topical base component mayinclude all or a portion of the local anesthetic component, such as oneor more local anesthetics, e.g., lidocaine or lidocaine and prilocaine.In one example, the topical base component may include about equalamounts of lidocaine and prilocaine, such as a lidocaine 2.5% andprilocaine 2.5% cream. In another example, the topical base componentmay include lidocaine, such as a 5% lidocaine ointment. Other initialamounts of lidocaine and/or prilocaine may be used. The method mayfurther include calculating an amount of actives needed and grinding upa suitable amount of the oral tablets containing the actives to obtainthe calculated amount of actives for the batch. The method may furtherinclude adding the fine powder of ground oral tablets to the topicalbase component and milling in an ointment mill and mixing.

An example application of the above method with respect to a compoundedtopical composition comprising lidocaine 2.25% by weight, prilocaine2.25% by weight, and acyclovir 8% by weight is provided. The antiviralcomponent comprises acyclovir obtained from grinding 800 mg acycloviroral tablets. The local anesthetic component comprises lidocaine andprilocaine obtained from a commercially manufactured/available lidocaine2.5% and prilocaine 2.5% cream that includes the topical base component.To calculate the weight of the powders needed, each gram of compoundedtopical component contains 8% acyclovir (or 80 mg acyclovir) which isequivalent to 0.1005 acyclovir 800 mg oral tablets, which is equivalentto 100.5 mg total weight of acyclovir 800 mg oral tablets. Based on thedetermination of the amount of tablets required to obtain the desiredamount of active, the number of tablets needed may be multiplied by theaverage weight of a tablet to obtain the weight of the tablet powderneeded. The tablets are ground into a fine powder and weighed to obtainthe desired weight of powder before combining. The fine powder is addedto the topical base comprising lidocaine 2.5% and prilocaine 2.5% cream.To calculate the weight of the cream needed, each gram of compoundedtopical composition comprises 2.25% lidocaine and 2.25% prilocaine,which is equivalent to 0.9 g lidocaine 2.5% and prilocaine 2.5% cream.The cream and acyclovir fine powder may be combined in an appropriatecontainer, such as an electronic mixer jar and mixed once on normalsetting. The mixture may then be milled. An Exakt 120S-450 three rollmill, front roller “1”, rear roller “3” is suitable. The milled mixturemay then be mixed once in the electronic mixer on normal setting. Theresulting compounded topical composition may then be packaged inappropriate containers, such as tubes.

Another example application of the above method with respect to acompounded topical composition comprising lidocaine 5% by weight andacyclovir 8% by weight is provided. The antiviral component comprisesacyclovir obtained from grinding 800 mg acyclovir oral tablets. Thelocal anesthetic component comprises lidocaine obtained from acommercially manufactured/available lidocaine 5% ointment that includesthe topical base component. To calculate the weight of the powdersneeded, each gram of compounded topical component contains 8% acyclovir(or 80 mg acyclovir) which is equivalent to 0.1005 acyclovir 800 mg oraltablets, which is equivalent to 100.5 mg total weight of acyclovir 800mg oral tablets. Based on the determination of the amount of tabletsrequired to obtain the desired amount of active, the number of tabletsneeded may be multiplied by the average weight of a tablet to obtain theweight of the tablet powder needed. The tablets are ground into a finepowder and weighed to obtain the desired weight of powder beforecombining. The fine powder is added to the topical base/lidocaineointment 5%. To calculate the weight of the ointment needed, each gramof compounded topical composition comprises 4.5% lidocaine, which isequivalent to 0.9 g lidocaine 5% ointment. The ointment and acyclovirfine powder may be combined in an appropriate container, such as anelectronic mixer jar and mixed once on normal setting. The mixture maythen be milled. An Exakt 120S-450 three roll mill, front roller “1”,rear roller “3” is suitable. The milled mixture may then be mixed oncein the electronic mixer on normal setting. The resulting compoundedtopical composition may then be packaged in appropriate containers, suchas tubes.

III. Methods of Administration and Treatment

As described above, a method of treating various viral ailments relatedto herpes simplex and varicella zoster. Treatment may include topicallyadministering a sufficient amount of the compounded topical compositiondescribed herein to an infected skin or mucosal area or area in whichinfection is sought to be prevented. The composition may be rubbed intosite or may be applied using a dressing or patch. Administration at thesite may be repeated twice a day, daily, for a duration of time asneeded for preventative treatment or treatment of a current infection.Treatment with the compounded topical composition may reduce frequencyand severity of outbreaks. Treatment with the compounded topicalcomposition may also reduce duration of outbreaks in infectedindividuals. Treatment with the compounded topical composition mayreduce risk of acquisition or transmission of the virus. In someembodiments, treatment with the compounded topical composition mayreduce shedding.

The grammatical articles “one”, “a”, “an”, and “the”, as used in thisspecification, are intended to include “at least one” or “one or more”,unless otherwise indicated. Thus, the articles are used in thisspecification to refer to one or more than one (i.e., to “at least one”)of the grammatical objects of the article. By way of example, “acomponent” means one or more components, and thus, possibly, more thanone component is contemplated and may be employed or used in anapplication of the described embodiments. Further, the use of a singularnoun includes the plural, and the use of a plural noun includes thesingular, unless the context of the usage requires otherwise.

This disclosure describes various elements, features, aspects, andadvantages of various embodiments, configurations, and arrangements ofthe compounded topical composition and methods thereof. It is to beunderstood that certain descriptions of the various embodiments and suchconfigurations and arrangements thereof have been simplified toillustrate only those elements, features and aspects that are relevantto a more clear understanding of the disclosed embodiments, whileeliminating, for purposes of brevity or clarity, other elements,features and aspects. Any references to “various,” “certain,” “some,”“one,” or “an” when followed by “embodiment,” “configuration,” or“arrangement” generally means that a particular element, feature oraspect described in the example is included in at least one embodiment.The phrases “in various,” “in certain,” “in some,” “in one,” or “in an”when followed by “embodiment”, “configuration”, or “arrangement” may notnecessarily refer to the same embodiment. Furthermore, the phrases “inone such” or “in this” when followed by “embodiment,” “configuration,”or “arrangement,” while generally referring to and elaborating upon apreceding embodiment, is not intended to suggest that the elements,features, and aspects of the embodiment introduced by the phrase arelimited to the preceding embodiment; rather, the phrase is provided toassist the reader in understanding the various elements, features, andaspects disclosed herein and it is to be understood that those havingordinary skill in the art will recognize that such elements, features,and aspects presented in the introduced embodiment may be applied incombination with other various combinations and sub-combinations of theelements, features, and aspects presented in the disclosed embodiments.It is to be appreciated that persons having ordinary skill in the art,upon considering the descriptions herein, will recognize that variouscombinations or sub -combinations of the various embodiments and otherelements, features, and aspects may be desirable in particularimplementations or applications. However, because such other elements,features, and aspects may be readily ascertained by persons havingordinary skill in the art upon considering the description herein, andare not necessary for a complete understanding of the disclosedembodiments, a description of such elements, features, and aspects maynot be provided. As such, it is to be understood that the descriptionset forth herein is merely exemplary and illustrative of the disclosedembodiments and is not intended to limit the scope of the invention asdefined solely by the claims.

What is claimed is:
 1. A compounded topical composition comprising: anantiviral component comprising one or more ground oral tablets of atleast one antiviral selected from acyclovir, valaciclovir, penciclovir,famciclovir, or a combination thereof, wherein the one or more groundoral tablets are dissolved, suspended, or combination thereof in thecompounded topical composition; a topical local anesthetic componentcomprising (a) a lidocaine 5% ointment containing the local anestheticlidocaine in an amount 5% by weight, (b) a lidocaine 2.5% and prilocaine2.5% cream containing the local anesthetics lidocaine and prilocaine,each in an amount of 2.5% by weight, (c) or both; and wherein the one ormore ground oral tablets of the antiviral component are present in anamount such that the compounded topical composition comprises theantiviral in an amount between about 4% and about 12% by weight of thecompounded topical composition.
 2. The compounded topical composition ofclaim 1, wherein the antiviral component comprises one or more groundoral acyclovir tablets containing the antiviral acyclovir present in anamount such that the compounded topical composition comprises theantiviral acyclovir in an amount between about 4% and about 12% byweight.
 3. The compounded topical composition of claim 2, wherein theone or more ground oral acyclovir tablets are present in an amount suchthat the compounded topical composition comprises the antiviralacyclovir in an amount between about 6% and about 9% by weight.
 4. Thecompounded topical composition of claim 2, wherein the one or moreground oral acyclovir tablets are present in an amount such that thecompounded topical composition comprises the antiviral acyclovir in anamount about 8% by weight.
 5. The compounded topical composition ofclaim 3, wherein the topical local anesthetic composition comprises thelidocaine 5% ointment, and wherein the lidocaine 5% ointment is presentin an amount such that the compounded topical composition comprises thelocal anesthetic lidocaine in an amount greater than 4% by weight. 6.The compounded topical composition of claim 5, wherein the one or moreground oral acyclovir tablets are present in an amount such that thecompounded topical composition comprises the antiviral acyclovir in anamount about 8% by weight and lidocaine in an amount about 4.5% byweight.
 7. The compounded topical composition of claim 3, wherein thetopical local anesthetic composition comprises the lidocaine 2.5% andprilocaine 2.5% cream, and wherein the lidocaine 2.5% and prilocaine2.5% cream is present in an amount such that the compounded topicalcomposition comprises each of the local anesthetics lidocaine andprilocaine in an amount between about 1.5% and about 2.25% by weight. 8.The compounded topical composition of claim 7, wherein the one or moreground oral acyclovir tablets and the lidocaine 2.5% and prilocaine 2.5%cream are present in amounts such that the compounded topicalcomposition comprises the antiviral acyclovir in an amount about 8% byweight and each of the local anesthetics lidocaine and prilocaine in anamount about 2.25% by weight.
 9. The compounded topical composition ofclaim 1, wherein the antiviral component comprises one or more groundoral acyclovir tablets containing the antiviral acyclovir and at leastone of (a) one or more ground oral valaciclovir tablets containing theantiviral valaciclovir or (b) one or more ground oral famciclovirtablets containing the antiviral famciclovir.
 10. The compounded topicalcomposition of claim 9, wherein the topical local anesthetic compositioncomprises the lidocaine 5% ointment, and wherein the lidocaine 5%ointment and the one or more ground oral acyclovir tablets and the atleast one of (a) the one or more ground oral valaciclovir tablets or (b)the one or more ground oral famciclovir tablets are present in amountssuch that the compounded topical composition comprises the antiviralsacyclovir and the at least one of valaciclovir or famciclovir in acombined amount between about 6% and about 9% by weight and the localanesthetic lidocaine in an amount greater than 4% by weight.
 11. Thecompounded topical composition of claim 10, wherein the lidocaine 5%ointment and the one or more ground oral acyclovir tablets and the atleast one of (a) the one or more ground oral valaciclovir tablets or (b)the one or more ground oral famciclovir tablets are present in amountssuch that the compounded topical composition comprises the antiviralsacyclovir and the at least one of valaciclovir or famciclovir in acombined amount about 8% by weight and the local anesthetic lidocaine inan amount about 4.5% by weight.
 12. The compounded topical compositionof claim 9, wherein the topical local anesthetic composition comprisesthe lidocaine 2.5% and lidocaine 2.5% cream, and wherein the lidocaine2.5% and prilocaine 2.5% cream and the one or more ground oral acyclovirtablets and the at least one of (a) the one or more ground oralvalaciclovir tablets or (b) the one or more ground oral famciclovirtablets are present in amounts such that the compounded topicalcomposition comprises the antivirals acyclovir and at least one ofvalaciclovir or famciclovir in a combined amount between about 6% andabout 9% by weight and each of the local anesthetics lidocaine andprilocaine in an amount between about 1.5% and about 2.25% by weight.13. The compounded topical composition of claim 12, wherein thelidocaine 2.5% and prilocaine 2.5% cream and the one or more ground oralacyclovir tablets and the at least one of (a) the one or more groundoral valaciclovir tablets or (b) the one or more ground oral famciclovirtablets are present in amounts such that the compounded topicalcomposition comprises the antivirals acyclovir and at least one ofvalaciclovir or famciclovir in a combined amount about 8% by weight andeach of the local anesthetics lidocaine and prilocaine in an amountabout 2.25% by weight.
 14. The compounded topical composition of claim1, wherein the antiviral component comprises at least one of (a) one ormore ground oral valaciclovir tablets containing the antiviralvalaciclovir or (b) one or more ground oral famciclovir tabletscontaining the antiviral famciclovir, and wherein the topical localanesthetic composition comprises the lidocaine 5% ointment.
 15. Thecompounded topical composition of claim 14, wherein the lidocaine 5%ointment and the at least one of (a) the one ground oral valaciclovirtablets or (b) the one or more ground oral famciclovir tablets arepresent in amounts such that the topical compounded compositioncomprises the at least one antiviral valaciclovir or famciclovir in acombined amount between about 6% and about 9% by weight and the localanesthetic lidocaine in an amount greater than 4% by weight.
 16. Thecompounded topical composition of claim 15, wherein the lidocaine 5%ointment and the at least one of (a) the one ground oral valaciclovirtablets or (b) the one or more ground oral famciclovir tablets arepresent in amounts such that the topical compounded compositioncomprises the at least one antiviral valaciclovir or famciclovir in acombined amount about 8% by weight and the local anesthetic lidocaine inan amount about 4.5% by weight.
 17. The compounded topical compositionof claim 1, wherein the antiviral component comprises at least one of(a) one or more ground oral valaciclovir tablets containing theantiviral valaciclovir or (b) one or more ground oral famciclovirtablets containing the antiviral famciclovir, and wherein the topicallocal anesthetic composition comprises the 2.5% and prilocaine 2.5%cream.
 18. The compounded topical composition of claim 17, wherein thelidocaine 2.5% and prilocaine 2.5% cream and the at least one of (a) theone ground oral valaciclovir tablets or (b) the one or more ground oralfamciclovir tablets are present in amounts such that the topicalcompounded composition comprises the at least one antiviral valacicloviror famciclovir in a combined amount between about 6% and about 9% byweight and each of the local anesthetics lidocaine and prilocaine in anamount between about 1.5% and about 2.25% by weight.
 19. The compoundedtopical composition of claim 18, wherein the lidocaine 2.5% andprilocaine 2.5% cream and the at least one of (a) the one ground oralvalaciclovir tablets or (b) the one or more ground oral famciclovirtablets are present in amounts such that the topical compoundedcomposition comprises the at least one antiviral valaciclovir orfamciclovir in a combined amount about 8% by weight and each of thelocal anesthetics lidocaine and prilocaine in an amount about 2.25% byweight.